Life-cycle approach: clinical evaluation intensified
Guidance on Authorized Representation (AR), Clinical Evaluation, Vigilance and Post-Market Clinical Follow-up has been integrated in the proposed MDR. Greater emphasis will be placed on clinical data. A Clinical Evaluation Report (CER) is imperative for all classes of devices and must be periodically updated. For implantable devices, an Expert Panel will be installed for clinical assessment.
To demonstrate Equivalence, referring to studies done with other devices, will be more challenging. One (!) Key equivalent device is allowed and clinical data for this device must be accessible. Furthermore, more clinical data must be obtained from market experience with the device. This includes active and continuous Post market surveillance with focus on safety and performance. We recommend to outlining a plan for Post market clinical follow up as early as possible.